Step into a pivotal role at Alexion as the Regulatory Affairs Manager in Canada. In this position, you will oversee critical regulatory submissions and collaborate with diverse teams, working in a flexible setting. This managerial position entails engaging in regulatory strategy development for pharmaceuticals, managing submissions to Health Canada, and working alongside cross-functional teams.

Your insights will facilitate compliance with regulations while ensuring timely completion of project deliverables, including the integration of AI tools. Key Responsibilities:

- Lead regulatory activities for key product portfolios
- Prepare NDS/SNDS submissions and oversee communications
- Ensure timely stakeholder updates on regulatory matters
- Collaborate on clinical trial submissions and oversight
- Maintain SOPs and conduct regulatory policy reviews

Requirements:

- 5+ years of experience in pharmaceutical Regulatory Affairs
- Strong grasp of Canadian Food & Drug guidelines
- Excellent detail orientation and project management
- Familiar with AI applications in regulatory settings
- Preferred MSc. or PhD. in a relevant field

Drive regulatory success and transformative healthcare projects at Alexion in Canada.

📌 Canada Regulatory Affairs Manager Role (Mississauga)
🏢 Alexion Pharmaceuticals,Inc.
📍 Mississauga